The present invention relates to ventilation and intubation, resuscitation and fiber-optic examination of the airway of patients.
More particularly, the invention provides an anatomically shaped ventilation and intubation device which can be used for inserting a tube into the trachea while allowing continuation of breathing, and can additionally be used for the insertion into the trachea of a fiber-optic probe, and for the resuscitation of a patient by mouth or by a mechanical ventilation device.
In regular practice of general anesthesia physicians use an endotracheal tube, which is a flexible tube made of a plastic material having an inflatable cuff surrounding its distal end. Introducing the endotracheal tube into the trachea is a skilled operation requiring the use of a laryngoscope in order to guide the tube through the larynx and past the vocal cords into the trachea. There is a risk that either the tube or the laryngoscope may damage the soft tissue of die sensitive structure of the larynx.
In some patients it is not possible to see the larynx. To offer an acceptable alternative solution for intubation by anesthesiologists and therapist personnel, many devices have been developed for airway management of patients.
The esophageal obturator airway has been used since 1972. However the efficacy of this device is still questionable. Furthermore, its use has been suspected of causing trauma of the esophagus.
In U.S. Pat. No. 5,499,625 Frass et al. disclose an esophageal-tracheal double lumen airway, similar to the esophageal obturator airway. The Frass device was commercialized under the trade name xe2x80x9cCOMBITUBExe2x80x9d. The airway serves for both sole esophageal obturator ventilation and for endotracheal intubation of a patient. The airway includes two lumens, one distal end being open, the other closed. The basic shape of the part of the device to be inserted is a flexible cylindrical tube, which is forced to conform to the shape of the throat during insertion.
Brain discloses an artificial airway device in U.S. Pat. No. 4,509,514, for use in place of an endotracheal tube to facilitate ventilation of an unconscious patient. A laryngeal mask comprises a tube opening into the interior of the inflatable mask adapted to seal around the larynx inlet. The uses of this device are said to be permitting ventilation, securing patient""s airway and preventing inhalation of extraneous matter. The device can also be used for endotracheal intubation.
A Laryngeal-mask airway with guide element, stiffener and fiberoptic access is disclosed by Brain in U.S. Pat. No. 5,682,880. The airway has a conventional distal-end mask structure. An external handle connected to the proximate end of reinforcement elements facilitates installation of the mask. Removal of the reinforcement elements exposes guide passages for fiberoptic devices, which devices help in the correct insertion of an endotracheal tube.
Greenberg introduced the cuffed oro-pharyngeal airway (COPA) in U.S. Pat. No. 5,443,063. The airway is intended to replace a face mask as used in maintaining general anesthesia. The inflatable cuff displaces the patient""s epiglottis for more effective gas delivery to the lungs. Greenbergs device however fails to provide an easier way to access the trachea in xe2x80x9ccannot intubate/cannot ventilatexe2x80x9d situations.
U.S. Pat. No. 5,694,929 Christopher discloses a method and apparatus for ventilation/oxygenation during guided insertion of an endotracheal tube, which is inserted during resuscitation by using a face mask and curved guide. Air/oxygen is supplied through the mask for initial resuscitation. The endotracheal tube is inserted over the distal end of a fiber optic probe. Resuscitation, oxygenation or artificial ventilation continue while the tube and probe are inserted through a flexible port at the proximate end of the curved guide and advanced into the patients airway. The direction of the probe tip can be controlled by the physician. The probe and mask are then removed, leaving the tube in the trachea.
Furthermore, tire resuscitation process is exposed to difficulties while using the face-mask. The incidence of difficult intubation in the general population varies between 1%-18%. Complete failed mask ventilation and endotracheal intubation frequently result in brain damage or death.
The management of the difficult airway was considered by the American Society of Anesthesiology (ASA) In 1991 the ASA developed the xe2x80x9cASA difficult algorithmxe2x80x9d, which is in continuous development since. The algorithm considers the appropriate options for management of the difficult airway, particularly for xe2x80x9ccannot intubate/cannot ventilatexe2x80x9d situations.
No prior-art device answers the need for an adequate and reliable solution for airway management, alternative to endotracheal intubation, and particularly the need for simultaneous ventilation/oxygenation of the patient, fiberoptic intubation and prevention of aspiration of the gastric fluid content.
A major shortcoming of prior-art devices is that the device shape is far from being in accordance with the shape of the organs into which they are to be inserted. Thus in addition to the trauma which brought about the need for medical intervention, the patient suffers further pain as the prior-art airway device is inserted and attempts to resume its original form.
It is therefore one of the objects of the present invention to obviate the disadvantages of prior art devices and to provide an anatomically formed airway device which can be used in routine intervention and in cases of difficult introduction, and allows tracheal intubation aided by a fiberoptic probe while providing simultaneous and continuous ventilation or oxygenation, while preventing gastric dilation and preventing aspiration of the gastric fluid content.
It is a further object of the present invention to seal the patient""s mouth and nose to allow positive pressure artificial ventilation, if needed.
Yet a further object of the present invention is to adapt the shape of the device to more closely match the shape of the oropharynx so that the device can be substantially painlessly inserted even by paramedics and first-aid personnel.
The present invention achieves the above objects by providing an anatomically-shaped airway ventilation and intubating device, comprising a flexible elongated conduit adapted to fit in a patient""s oropharynx, said conduit having a proximate end and a distal end, said conduit being partially divided by a septum into a ventilation lumen and an intubation lumen, said lumens being in fluid communication to a first opening at said distal end to be substantially opposite the laryngeal opening of the patient when inserted, and wherein a second opening is provided at said proximate end, said second opening being in fluid communication with said ventilation lumen; whereby said intubation lumen is adapted to accommodate an endotracheal tube that can be inserted while enabling breathing of patient through said ventilator lumen and whereby after said endotracheal tube is inserted said first opening may be sealed while patient""s breathing is directed through said endotracheal tube.
In a preferred embodiment of the present invention there is provided an anatomically-shaped airway intubating device further provided with a third opening in fluid communication with said intubation lumen, said third opening being provided with a valve allowing the insertion therethough of a fiber-optic probe into said intubation lumen.
In a further preferred embodiment of the present invention there is provided an anatomically-shaped airway ventilation and intubating device wherein the two openings of largest diameter are in horizontal side-to-side formation with the smallest of said three openings being located between ad largest openings and spaced apart from the center-line joining said largest openings.
In a further preferred embodiment of the present invention there is provided an anatomically-shaped airway ventilation and intubating device, further provided with an elongated endoesophageal lobe at said distant end adapted to be inserted through the patient""s upper esophagus.
In a most preferred embodiment of the present invention there is provided an anatomically-shaped airway resuscitating device, comprising a flexible elongated conduit adapted to fit in a patients oropharynx, said conduit having a proximate end and a distal end, said conduit being partially divided by a septum into an inspiratory lumen and an expiatory lumen, said lumens being in fluid communication to a first opening at said distal end to be substantially opposite the laryngeal opening of the patient when inserted, and wherein a second and a third opening are provided at said proximate end, said second opening being in fluid communication with said inspiratory lumen and said third opening being in fluid communication with said expiatory lumen, said second opening being provided with a one-way valve allowing air to enter said inspiratory lumen.
It will thus be realized that the novel device of the present invention serves to provide an alternative to endotracheal intubation, a procedure which may be impossible, or undesirable during some elective operations, or too risky in difficult cases. Nevertheless, if it is possible and desirable to insert an endotracheal tube, the device of the present invention allows this to be carried out without any interruption of ventilation. Even where intubation is carried out, this will usually be possible without the use of a bronchoscope. If however it is considered necessary to use such instrument, a passage therefor is provided by the airway of the present invention.
Simply by rearranging the positions of the entry ports of the various lumens, the outer dimensions and shape of the device can be much better suited to the natural shape of the oral cavity and pharynx. The device can be produced in various sizes, and color coded, to suit the oropharynx of different sections (children, adults) of the population.
The device can be used in emergency care of cardiac arrest, near drowning, coma, trauma and any circumstances where free airway ventilation is necessary and gastric aspiration must be prevented.
The device is easily inserted, and due to its shaped exterior can even be inserted blindly.
The resuscitator embodiments of the invention are suitable for use in emergency medicine, and insertion of the airway into a patient can be effected by first aid personnel and paramedics, as due to the anatomical shape of the device, no particular skill is required. A doctor is often unavailable in an emergency situation, and in the meantime, a paramedic, a sea or swimming pool life guard, or a civil defense rescue worker, for example, may save a patient by using the airway device by restoring breathing by connecting air or oxygen or the rescue person""s breath into the inspiratory lumen while allowing used air containing carbon dioxide to flow out of the expiratory valve.
The invention will now be described further with reference to the accompanying drawings, which represent by example preferred embodiments of the invention. Structural details are shown only as far as necessary for a fundamental understanding thereof. The described examples, together with the drawings, will make apparent to those skilled in the art how further forms of the invention may be realized.